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Halozyme Presents PEGPH20 Phase 1b Clinical Trial Data at European Cancer Congress 2013
Date:9/30/2013

SAN DIEGO, Sept. 30, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced mature patient progression free survival (PFS) and ongoing overall survival (OS) data from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. In the trial, both PFS and OS data suggest a potential clinical benefit of using PEGPH20 with gemcitabine in patients with high levels of tumor associated hyaluronan (HA). These results are being presented at European Cancer Congress 2013 (ECCO-ESMO-ESTRO) in a poster session at 14:00 CEST (Hall 4, Abstract #2598). Early response rates from this trial were previously presented at the 2013 American Society of Clinical Oncology (ASCO) Annual meeting in June 2013.

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The accumulation of HA, a protective matrix that surrounds many solid tumors, has been shown to be an indicator of poor patient prognosis and may accelerate disease progression. In this single arm study, all patients received PEGPH20 in combination with gemcitabine. The primary objective was to determine the recommended phase 2 dose. Exploratory analysis evaluated PFS and OS in a subset of patients with available biopsy samples and HA scores. In patients with high levels of tumor HA (n=6), PFS was 219 days compared to 108 days for patients with low levels of tumor HA (n=11), while OS in the high HA group was 529 days compared to 174 days for the low HA group. OS data is still not mature for the high HA group. With respect to the intent to treat population irrespective of HA status (n=24), PFS was 154 days and OS was 200 days.

"PEGPH20 has been shown in animal studies to deplete H
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SOURCE Halozyme Therapeutics, Inc.
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